Health care's nanotechnology hopes

Nanomaterials promise better drugs, but concerns remain

SAN FRANCISCO (MarketWatch) -- Health-care companies are thinking small, extremely small, to develop what they hope will be the next big thing.

Nanotechnology -- the use of particles much tinier than cells -- is emerging as a powerful complement to biotechnology, nanotech experts said.

It's an area that promises to make drug delivery, diagnosis and treatment of diseases like cancer more efficient by enabling therapies to target only harmful cells, be absorbed in the bloodstream better and slip past immune-system responses that trigger toxic side effects.

Nanotechnologies also have the potential to improve diagnostics by creating new ways of imaging and assessing the states of the body based on properties unique to nanoscale materials, said Jason Robert, assistant life-sciences professor at Arizona State University in Tempe.

Another category ripe for nano improvement is implants, Robert said. Nanoparticles may make implants more stable and long-lasting.

In drugs, nanoparticles may be able to pass the blood-brain barrier, allowing for better therapies for a host of neurological ailments.

Nanotech has been around for several decades but has been concentrated in industrial products such as automotive coatings, said Joseph DeSimone, a chemistry and chemical engineering professor at the University of North Carolina-Chapel Hill.

Scientists are taking techniques used in electronics manufacturing and translating them to medicine, where breakthroughs using nanotech with organic chemistry are laying the groundwork for major developments, said DeSimone, who co-founded Liquidia Technologies in Research Triangle Park, N.C.

"We now have students and people really good at nanotechnology learning about cancer biology and applying tools of nanotech for detecting and treating and ultimately preventing cancer and other diseases like inflammation and cardiovascular disease," DeSimone said. "It's a really exciting time."

Products such as stitches that don't need to be removed serve as a model, he said. "We have nanoparticles made out of materials that behave like bioabsorbable sutures, so they can fall apart selectively where you want them to and release cargo, therapy, medicines."

Nanoparticles are typically less than 500 nanometers, he said. A nanometer is a billionth of a meter. "These particles can be many times smaller than light itself."

Getting past barriers

Today, many critical drug ingredients can't penetrate a cell's wall or substructures because the molecules are too large, said Bill Martineau, a health-care consultant for the Freedonia Group, a research and consulting firm in Mayfield Village, Ohio.

That's what makes nanosizing compelling to big pharmaceutical companies, many of which are looking to partner with nanotech-focused firms, he said.

"I see the largest application in drug delivery if they can prove it's safe and effective," Martineau said. "There's got to be some kind of targeting for these things so they don't get into healthy cells and cause problems."

Eventually, nanotechnologies may enable tissue regeneration, where scientists could grow artificial skin or new organs, and gene therapy, Martineau said.

Demand for nanotech health-care products is projected to hit $6.5 billion in 2009, up from $906 million in 2004, according to a 2005 report from the Freedonia Group. The total market may exceed $100 billion by 2020. Sales of pharmaceuticals created or modified with nanoparticles will grow to $16.6 billion by 2014, the group said.

Several nano drugs already are on the market. Cancer drug Abraxane made by Abraxis Bioscience
ABBI
was designed as a next-generation, nano-version of Taxol, a treatment for advanced breast cancer, Martineau said. The U.S. Food and Drug Administration approved it in January 2005.

Other available nano drugs include Rapamune, developed by Wyeth Pharmaceuticals
WYE
and approved in 1999 to prevent organ rejection in kidney transplant patients. Merck
MRK, +1.85%
makes Emend, which prevents chemotherapy-induced nausea and vomiting, and Novavax
NVAX, +2.10%
developed Estrasorb, a hormone-replacement therapy that's rubbed onto the skin and made of a nanoemulsion formulation.

Smith and Nephew
SNN, +2.19%
partners with Nucryst Pharmaceuticals
NCST
to distribute a line of nanosilver-formulated antimicrobial wound dressings called ActiCoat.

Elan
ELN, +0.00%
has had particular success using its NanoCrystal technology to reformulate drugs and make them easier for patients to take. For example, the company uses its nanotechnology in the antirejection agent Rapamune, which the body is better able to absorb than previous treatments, said Paul Breen, head of Elan's drug technologies in Dublin, Ireland.

"We eliminated the need to make a complicated mixture and the patient was able to take a tablet," Breen said.

The company is testing more than 70 compounds with nanotechnology, he said.

"We make the particles so small that they easily cross over the biological barriers," Breen said. "Particles of that size tend to want to clump together to go back to bigger particles. Part of our technology is not only reducing the size to an extremely nanoscale, but also stabilizing them there so they can easily pass through the cell wall and into the bloodstream."

Supplements and gold

Not all companies are choosing drug delivery to harness their nanotechnology. At Five Star Technologies in Cleveland, the focus is on supplying other companies with nanodispersions of nutritional supplements, said Tim Fahey, vice president of business development.

"That provides advantages like better taste in liquid supplements or better bioavailability to get into the body faster," he said. "We are able to make the dispersions to re-present other people's [products] so they can take better versions of them to market."

Skipping the lengthy, costly clinical trials required for marketing drugs and focusing instead on "nutraceuticals" allows for a shorter path to commercialization, Fahey said. "Our customers get products to market in a matter of a year rather than 10 years."

Diagnostics also stand to gain. Dr. Ivan El-Sayed, assistant professor in head and neck oncologic surgery at the University of California-San Francisco Medical Center, studies gold nanorods. He said nanotechnology may serve a dual role in making diagnosis and surgery for treatment safer.

While research is still in the early stages, he said gold's properties at the nanoscale may lead to a noninvasive test that makes cancer screening easier. It also may enable alternative cancer treatments where light is used to heat nanorods, which in turn kill tumor cells.

"Our current methods of treating the tumor are with surgery or radiation," El-Sayed said. "A therapy like this you should hypothetically be able to give repeated treatments or give instead of radiation. What the best use of it would be will be determined in future years, depending on how effective it is and what the problems with it are."

Safety concerns

The FDA doesn't require specific procedures for testing the safety of nanotech products beyond what's required for all its regulated products.

But the agency recently announced it will hold a public meeting this fall to "further its understanding" of developments in the use of nanotechnology in FDA-regulated products.

How the FDA will characterize hybrid applications like nanosize coatings on implants will be important, Robert said. "Are we going to characterize these as nano devices or are we going to call them biologicals, which puts them down a different regulatory pathway at the FDA? It's much easier to get devices approved than biologicals."

Companies need to help create rigorous safety protocols for nanotech agents because promoting a product that turns out to be harmful could affect the whole industry, said Robert, theme leader of the human identity, enhancement and biology program at Arizona State University's Center for Nanotechnology in Society.

"Let's say first generation of these products is fine but the next generation turns out to be highly toxic," he said. "Even if it's just one bad product or one particular technology that causes some damage, there could be a backlash that cuts across a huge sector of manufacturing, scientific research and drug discovery."

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